21 CFR 864.8625 — Standards And Controls, Hemoglobin, Normal And Abnormal
Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8625
Identification
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Classification Rationale
Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GFS | Standards And Controls, Hemoglobin, Normal And Abnormal | 2 | 1 | |
| GGL | Control, White-Cell | 2 | 8 | |
| GGM | Control, Hemoglobin | 2 | 15 | |
| GJP | Control, Platelet | 2 | 4 | |
| GJR | Control, Red-Cell | 2 | 5 | |
| GLK | Control, Hematocrit | 2 | 7 | |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 2 | 10 | |
| JCN | Control, Cell Counter, Normal And Abnormal | 2 | 12 | |
| JPK | Mixture, Hematology Quality Control | 2 | 192 | |
| MZG | Test, Residual, Wbc In Leukoreduced Blood | 2 | 0 | |
| NRF | Material, Quality Control, Semen Analysis | 2 | 3 | |
| NRS | Control Material, Blood Circulating Epithelial Cancer Cell | 2 | 1 |
Special Controls
GFS — Standards And Controls, Hemoglobin, Normal And Abnormal
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GGL — Control, White-Cell
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GGM — Control, Hemoglobin
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GJP — Control, Platelet
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GJR — Control, Red-Cell
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GLK — Control, Hematocrit
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GLQ — Mixture, Control, White-Cell And Red-Cell Indices
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JCN — Control, Cell Counter, Normal And Abnormal
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JPK — Mixture, Hematology Quality Control
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
MZG — Test, Residual, Wbc In Leukoreduced Blood
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
NRF — Material, Quality Control, Semen Analysis
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
NRS — Control Material, Blood Circulating Epithelial Cancer Cell
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
